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Alkylating agents

Chemotherapy Response Prediction for Breast Cancer (RESPONSE Trial)

Phase 2

Recruiting

Led By Mothaffar Rimawi, MD

Research Sponsored by Baylor Breast Care Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed, invasive breast cancer. Tumor may be triple negative, HER2-positive, or high-risk estrogen receptor positive

Tumors must be at least 2 cm by clinical exam or ultrasound

Must not have

Definitive clinical or radiologic evidence of Stage IV disease

History of an excisional biopsy or lumpectomy performed prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether the amount a tumor shrinks before surgery can predict how much of the tumor will remain after surgery.

Who is the study for?

This trial is for adults with invasive breast cancer that's at least 2 cm large, including triple negative, HER2-positive, or high-risk estrogen receptor positive types. Participants must be able to consent and use non-hormonal contraception if applicable. They should have good organ function and heart health but no severe diseases, HIV/hepatitis infections, recent other cancers, psychiatric issues preventing study compliance, prior breast cancer treatments or surgeries.

What is being tested?

The study tests whether the shrinkage of a tumor from chemotherapy before surgery can predict how much tumor remains at surgery time. It involves drugs like Carboplatin and Trastuzumab among others in patients with early-stage breast cancer to see if physical changes correlate with surgical findings.

What are the potential side effects?

Possible side effects include allergic reactions to medications; heart problems due to Doxorubicin; blood disorders from Carboplatin; nerve damage or joint pain from Paclitaxel; immune-related issues from Pembrolizumab; and general symptoms like nausea, fatigue or infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is confirmed and may be triple negative, HER2-positive, or high-risk estrogen receptor positive.

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My tumor is at least 2 cm in size.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My organs are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is confirmed to be at Stage IV.

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I have had a lumpectomy or excisional biopsy before joining the study.

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I have been diagnosed with inflammatory breast cancer.

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I do not have heart conditions that would prevent me from taking certain cancer treatments.

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I do not have HIV, hepatitis B, or hepatitis C.

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I have received treatment for my current breast cancer diagnosis.

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I have not had any cancer other than breast cancer in the last 5 years.

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I have been treated with anthracyclines for cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Clinical Tumor Measurement vs. Pathologic Response

Secondary study objectives

Pathologic Complete Response Rate in each Breast Cancer Subtype

Pharmacotherapy

Other study objectives

Change in circulating tumor DNA (ctDNA) levels from baseline to surgery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Triple Negative Breast Cancer (for tumors > 5 cm)Active Control5 Interventions

Paclitaxel IV plus carboplatin IV (+/- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+/- pembrolizumab IV) (4 cycles total)

Group II: HER2-Positive Breast CancerActive Control6 Interventions

Paclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total)

Group III: Triple Negative Breast Cancer (for tumors < 5 cm)Active Control3 Interventions

Paclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)

Group IV: Hormone Receptor Positive Breast CancerActive Control3 Interventions

Paclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)

0 / 12Eligibility criteria met